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Status unknownNCT03550079Updated Jun 13, 2018

Fixation for the Treatment of Femoral Neck Fractures

An interventional study of fixation in Femoral Neck Fracture, sponsored by Hebei Medical University Third Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-06-13.

Sponsored by Hebei Medical University Third Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2017, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Sex
All
01

Study summary

The femoral neck fracture is the most prevalent injuries which commonly encountered among older people with high mortality, morbidity and young fit healthy ones who subjected to high-energy trauma . Non-union or avascular necrosis of femoral neck fracture which lead to loss of labor capacity and death, is the most commonly occurred complication and results in considerable burden for family. The treatment is difficult and challenging, and to minimize the negative results such as limited mobilization or other complications, it is essential to take active prevention and appropriate treatment depending on fracture pattern and patients' characteristics as early as possible. However, current implant selections for femoral neck fractures remain a topic of greater interest and controversy, and vary substantially from each other .

Read the detailed description

The incidence of femoral neck fracture accounts for 3.6% of all fractures, is the most prevalent injuries which commonly encountered among older people with high mortality, morbidity and young fit healthy ones who subjected to high-energy trauma . Non-union or avascular necrosis of femoral neck fracture which lead to loss of labor capacity and death, is the most commonly occurred complication and results in considerable burden for family. The treatment is difficult and challenging, and to minimize the negative results such as limited mobilization or other complications, it is essential to take active prevention and appropriate treatment depending on fracture pattern and patients' characteristics as early as possible. However, current implant selections for femoral neck fractures remain a topic of greater interest and controversy, and vary substantially from each other depending on the extent of displacement, fracture configuration, physiological age of the patient, bone quality or other relative factors. Nonoperative management is considered only when patients are seriously ill or presented with excessive surgical risk.

02

Conditions studied

  • Femoral Neck Fracture
03

In context

Femoral Neck Fractures

212 studies on the registry are indexed under Femoral Neck Fractures; 43 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 148 interventional studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Hebei Medical University Third Hospital is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • closed femoral neck fracture
  • no fractures at other sites
  • surgical treatment with cannulated compression screws or PFNA
  • follow-up time greater than 1 years.

Exclusion criteria

Exclusion Criteria:

  • the absence of severe cognitive dysfunction,
  • the presence of a pathological femoral neck fracture
  • previous femoral neck fracture, treated with other internal fixations and surgical treatment with open reduction.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    three screws fixation

    femoral neck fractures were fixed with three converted screws

    Procedure: fixation

  • Experimental
    four screws fixation

    femoral neck fractures were fixed with four screws

    Procedure: fixation

Interventions

  • Procedurefixation

    treated with different fixation method

06

What researchers measure

Primary outcomes

  1. outcome measure were evaluated by femoral neck shortening with X rays

    femoral neck shortening after 1 year with radiology measure,

    Time frame: up to 12 months

Secondary outcomes

  1. nonunion

    the number of nonunion at the end of follow up in patients

    Time frame: up to 12 months

  2. screw-exit

    screw-exit afer 1 year with X rays in all patients

    Time frame: up to 12 months

  3. cut-out

    cut-out of the screw evaluating with x rays in all patients

    Time frame: up t 12 months

Other outcomes

  1. operative time in every patient

    outcome measure were evaluated by operative time

    Time frame: intraoperation

  2. fluoroscopy time intraoperatively

    outcome measure were evaluated by operative time and fluroscopy time

    Time frame: intraoperation

07

Study locations

1 of 1 sites recruiting
  • the Third Hospital of Hebei Medical University
    Shijiazhuang, Hebei 050000, China
    Recruiting
    • Chen Wei · Contact
08

References and documents

Publications

  • Guo J, Dong W, Yin B, Jin L, Lin Z, Hou Z, Zhang Y. Intramedullary nails with cannulated screw fixation for the treatment of unstable femoral neck fractures. J Int Med Res. 2019 Feb;47(2):557-568. doi: 10.1177/0300060518816185. Epub 2018 Dec 11. PubMed 30526163 ↗

Individual participant data

Plan to share: No — the data should be allowed by Zhang Yingze

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03550079
Lead sponsor
Hebei Medical University Third Hospital
Responsible party
Sponsor
First posted
Jun 8, 2018
Start date
Oct 1, 2017
Primary completion
Dec 30, 2018 (estimated)
Completion
Dec 30, 2018 (estimated)
Last update
Jun 13, 2018

Study contacts

Zhang Yingze
Contact
dryzzhang@126.com
18533112888
Hou Zhiyong
Contact
drzyhou@gmail.com
18533112800
zhiyong Hou, MD
study director · Hebei Medical University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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